After being rejected two years ago, the U.S. Food and Drug Administration (FDA) has finally approved Novo Nordisk's anti-diabetic drug, Tresiba last Sept. 25.
Tresiba was initially disapproved by the FDA due to the lack of data on the risk for heart problems due to using the medication. However, after reapplying last March, Tresiba, along with another Novo Nordisk made drug, Ryzodeg, was approved for use in the U.S. after passing four 26-week then two 52-week long controlled clinical trials on 2,702 patients.
"Long-acting insulins play an essential role in the treatment of patients with type-1...and type-2 diabetes with advanced disease," said Dr. Jean-Marc Guettier, director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research, adding that the FDA remains committed in continuing the development of new and safe treatment options for diabetes patients.
The Denmark-based company behind Tresiba is pleased with the FDA's approval, believing that their product will be helpful to many American diabetics.
"We are very happy with FDA's decision to approve Tresiba and Ryzodeg as we believe these products offer significant benefits and important treatment options for people with type 1 and type 2 diabetes", said Lars Rebien Sørensen president and chief executive officer of Novo Nordisk. Sørensen added that this approval is a milestone for the company.
Tresiba is a long-acting insulin used to control blood sugar levels of type-1 and type-2 diabetics. Like with all insulins, it is to be injected subcutaneously, preferably before meals. Dosing for this medication should be tailored to fit individual patient needs, especially when used in combination with other rapid or short acting insulins. Patients and caregivers are advised to monitor blood sugar levels before and after use.
According to Todd Hobbs, Novo Nordisk North America's chief medical officer, Tresiba can last up to 42 hours compared to Levemir, the company's long acting insulin which only lasts for 18 to 24 hours.
"We want to do everything we can to make it as affordable and as broad of an access as we can," Hobbs said.
Prior to being approved for the U.S. market, Tresiba is already available in at least 30 other countries.
Photo: Yusmar Yahaya | Flickr
